QC Scientist III - Analytical Support
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Actalent
Remote
$83,200 Salary, Full-Time
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Job Description
Job Title:
QC Scientist III - Analytical Support Job Description The QC Scientist III (Analytical Support) plays a crucial role in providing technical input for analytical proposals, work statements, test methods, investigations, risk assessments, and client inquiries. This position requires adherence to Current Good Manufacturing Practices (cGMP) while supporting Commercial and Clinical Biopharmaceutical Manufacturing in line with Corporate Standards. Responsibilities Provide technical input for analytical proposals, work statements, test methods, investigations, risk assessments, and client inquiries. Collaborate cross-functionally to develop and implement departmental policies and procedures. Assist in technical training for analysts, data reviewers, and investigation writers. Interface between departments during method transfer, qualification, and validation. Perform method risk assessments prior to validation activities. Advise on language for CAPAs to ensure compliance with analytical methods, SOPs, site policies, and scientific robustness. Participate and support in FDA inspections, ISO and customer audits, and manage external audit responses for analytical concerns. Attend new client meetings and on-site visits, maintaining high involvement with clients during method validation and transfer. Manage critical reagent changes and review/approve internal reference material qualifications and recertifications. Expand scientific, technical, and compliance knowledge through relevant literature, industry conferences, and training. Participate in continuous process improvement initiatives and support site safety initiatives. Perform other job duties as assigned. Essential Skills Minimum of 3-5 years ofHPLC/UPLC
experience in quality/analytical/pharmaceutical industry. Experience withHPLC/UPLC
assays such as SEC, CEX, Glycans, Peptide Map. Prior use of EMPOWER is preferred. Knowledge of GMP regulations in a cGMP manufacturing environment. Working knowledge of scientific principles for various analytical techniques. Experience with ICH and FDA guidelines. Proficiency in MS Excel, MS PowerPoint, MS Teams, and MS Word. Outstanding technical reading and writing skills. Experience in analytical theory and technical competency of various characterization techniques. Additional Skills & Qualifications Bachelor's Degree in a Biological Science related field (preferably Chemistry, Biochemistry). 3+ years of experience in a GMP facility (biopharmaceutical or pharmaceutical industry) in a quality control role. 1+ years of experience in a client-facing quality control role. Experience with audit responses, data trends, and quality pharmaceutical regulations. Strong interpersonal skills including active listening and conflict resolution. Ability to build strong relationships with clients and instill trust and confidence. Highly organized with attention to detail and proven time management skills. Familiarity with project management concepts, tools, and responsibilities. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness. Work Environment This role involves working Monday to Friday, starting with 3 months of training from 8:00 am to 4:30 pm, with a flexible start time post-training to cover core hours from 9 am to 3 pm. Once fully trained, there is flexibility to work from home one day a week. The position involves desk work with 10% standing/walking and 90% sitting. Personal Protective Equipment (PPE) such as lab coats, gloves, eye protection, and safety shoes are required. There may be exposure to fumes, chemicals, acids, and bases. Job Type & Location This is a Contract to Hire position based out of Berkeley, MO. Pay and Benefits The pay range for this position is $38.00 - $42.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Berkeley,MO.
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